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Imaging Fibrogenesis in Renal Transplantation Patients Using Hyperpolarized Pyruvic Acid MRI

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

In this research, individuals who have received a kidney through Renal transplantation are examined to learn more about how the new kidney works. The study uses an investigational agent called Hyperpolarized [1-13C]pyruvate, which is given as a small injection into a vein. This agent contains pyruvic acid, a natural substance that cells use for energy, and it helps create a clear picture of kidney metabolism when scanned.

The purpose of the study is to describe kidney metabolism in transplant recipients using advanced imaging. Participants receive the injection and then undergo a special scan called MRI, which produces detailed images of the kidney without surgery. Over the course of the study, blood and urine samples are collected, and routine follow‑up visits are scheduled to monitor health and gather additional information.

Key measurements include the imaging results from the scan, changes in kidney function measured by eGFR (a blood test that estimates how well the kidneys filter waste), and assessment of fibrosis (the formation of scar tissue) from biopsy samples. Additional analyses involve looking at metabolites in blood and urine and reviewing medical records for any signs of long‑term kidney problems.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First Study Visit

    You will meet the study team for the initial visit after joining the trial. During this visit, the team will review your medical history related to renal transplantation and collect baseline blood and urine samples. Your kidney function will be measured using the eGFR test, and a standard magnetic resonance imaging (MRI) scan of the transplanted kidney will be performed without any study medication.

  2. Step 2

    Preparation for Hyperpolarized MRI

    Before the imaging session, you will be asked to follow any fasting or medication instructions provided by the study. The staff will check your vital signs and confirm that you have no contraindications for an intravenous procedure. They will also explain the purpose of the hyperpolarized [1-13C]pyruvate injection and answer any questions you may have.

  3. Step 3

    Hyperpolarized MRI Session

    During the MRI appointment, a small dose of hyperpolarized [1-13C]pyruvate will be given through an intravenous injection. The dose is 0.43 millilitre per kilogram of your body weight. Immediately after the injection, the MRI scanner will acquire images that show how the transplanted kidney processes the substance. The imaging portion of the visit typically lasts only a few minutes.

  4. Step 4

    Post‑Scan Monitoring

    After the scan, you will be observed for a short period to ensure that no immediate side effects occur from the injection. Additional blood and urine samples may be taken at this time to support the study's metabolic analyses.

  5. Step 5

    Follow‑Up Visits

    You will return for scheduled follow‑up visits throughout the trial. Each visit may include another hyperpolarized MRI scan, repeat measurements of eGFR, and collection of blood and urine for metabolomics testing. If the protocol requires, a small kidney tissue sample (biopsy) may be obtained during a follow‑up visit to assess fibrosis.

  6. Step 6

    Final Assessment

    At the end of the study period, a final set of evaluations will be performed. This includes the last hyperpolarized MRI scan, final kidney function testing, and completion of all planned laboratory analyses. The study team will then close your participation in the trial.

Who can join the trial?

2 criteria

  • Age: You must be 18 years old or older.
  • First kidney transplant: You must have received your first kidney transplant from a donor who has died, and this surgery must have taken place between 2 and 12 months before you join the study. (A “deceased donor” is a person who has passed away and donated their kidney.)

Who cannot join the trial?

4 criteria

  • Allograft (transplanted kidney) has failed and you have had to start dialysis (a machine that cleans the blood) again before the study begins.
  • You are currently experiencing allograft rejection, which means your body’s immune system is attacking the transplanted kidney.
  • Your doctor feels that not enough time has passed since a previous rejection episode, so you are not eligible yet.
  • You cannot take part if you have any of the following that make the special MRI unsafe: a pacemaker (heart device), a neurostimulator (device that sends signals to nerves), a cochlear implant (ear device), any metal pieces inside the body such as fragments or piercings that cannot be removed, implanted devices whose safety in MRI is unknown (for example, artificial heart valves or joint replacements), severe fear of closed spaces (claustrophobia), a body size where the total circumference including arms is larger than 160 cm, metal stents or other devices near the kidneys that could distort the images, a known allergy (hypersensitivity) to pyruvate or any part of the special imaging substance, or if you are currently pregnant or breastfeeding.
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Investigated drugs

Hyperpolarized [1-13C]pyruvate is a specially prepared form of pyruvic acid that is injected into a vein. In this study it is used as a contrast agent for magnetic resonance imaging (MRI). The hyperpolarized version makes the pyruvate shine brightly on the MRI scanner, allowing doctors to see how the transplanted kidney processes energy. By looking at these images, researchers can learn about the kidney’s metabolism and how well the transplanted organ is functioning. This helps them understand the process of fibrogenesis (scar tissue formation) in patients with kidney transplants.

What is already known about the treatment

Hyperpolarized [1-13C]pyruvate - It is administered as an intravenous injection of a specially prepared pyruvic acid solution that has been hyper‑polarized for magnetic resonance imaging. The agent is still experimental and is used mainly in research studies to image kidney transplants, not yet approved as a routine medication. It works by allowing doctors to watch how the transplanted kidney converts pyruvate into lactate and other metabolites, showing the organ’s energy metabolism. This substance is classified as a metabolic imaging agent used for diagnostic imaging.

Investigated diseases

Kidney transplant - Kidney transplant is a surgical procedure in which a healthy kidney from a donor is placed into a person whose own kidneys no longer work properly. After the operation, the new kidney takes over the role of filtering waste and excess fluid from the blood. Over time, the transplanted kidney may undergo gradual changes such as scarring and reduced filtering ability. These changes can be detected by imaging and biopsy. The function of the kidney is monitored by measurements of blood filtration rate and other laboratory tests. The condition is followed to understand how the organ adapts and ages within the recipient.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526669-17-00Estimated enrolment15 patientsSponsorAarhus Universitet

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